Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
Applicants filed claims 1 – 20 with the instant application on 11 August 2025. Currently, claims 1 – 20 are available for substantive examination.
Information Disclosure Statement
The Examiner has considered the information disclosure statement (IDS) filed 17 November 2025, which is now of record in the file.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that forms the basis for all obviousness rejections set forth in this Office Action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 37 CFR § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 1 – 20 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2015/0366641 A1 to Malinin, T. and A. Garg, filed 19 June 2014, and published 24 December 2015, identified on the Information Disclosure Statement (IDS) filed 17 November 2025, cite no. 1 (USPATAPP) ("Malinin '641"), in view of US 2017/0128634 A1 to Malinin, T., published 11 May 2017, identified on the IDS filed 17 November 2025, cite no. 2 (USPATAPP) ("Malinin '634"), and Malinin, T., et al., Implant Dentistry 18(5): 420 - 423 (2009), identified on the IDS filed 17 November 2025, cite no. 1 (NPL) ("Malinin (2009)").
The Examiner notes that Malinin '641 is applied as of its publication date as a § 102(a)(1)-type reference and is also applied as of its earliest effectively filed date as a § 102(a)(2)-type reference.
The applied reference (Malinin '641) has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art pursuant to
35 U.S.C. § 102(a)(2).
This rejection pursuant to 35 U.S.C. § 103 might be overcome by: (1) a showing under 37 CFR § 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing pursuant to 37 CFR § 1.130(b) of a prior public disclosure pursuant to 35 U.S.C. § 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. § 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person, or subject to an obligation of assignment to the same person, or subject to a joint research agreement. See, generally, MPEP § 717.02.
The Invention As Claimed
Applicant claims a method of making a bone graft composition, the method comprising the steps of generating a self-sustaining solid construct by drying a mixture of bone particles in water, saline, or other aqueous solution while in a constraining device, or under pressure, the solid construct substantially free of bonding materials and having sufficient structural integrity to retain metallic pins and screws, wherein the bone particles comprise at least partially decalcified cortical elongate bone shards and/or fluff having a length between about 1 mm and about 10 mm and a diameter between about 50 microns and about 500 microns, wherein the solid construct includes at least 70% by weight of the at least partially decalcified cortical elongate bone shards and/or fluff, wherein the at least partially decalcified cortical elongate bone shards or fluff were cut from dehydrated bone tissue comprising shafts of long bone or cortical tables of flat bones before being at least partially decalcified in a decalcifying solution, and wherein the bone particles, including the at least partially decalcified elongate bone shards and/or fluff, were hydrated in the water, saline, or other aqueous solution prior to the drying in the constraining device or under pressure, wherein the bone tissue was dehydrated using freeze-drying, hypothermic dehydration, without freezing, or chemical dehydration, wherein the bone tissue was harvested from shafts of long bone or cortical tables of flat bones of a mammal, wherein the bone tissue was harvested postmortem or from surgically removed bone specimens, wherein the mammal is one of a primate, an equine, a bovine, or a porcine, wherein the primate is a human, wherein the human postmortem bone was excised aseptically without muscle tendon or fascial attachments, wherein the bone particles were dried in the constraining device, wherein the dehydrated cortical bone tissue was cut with a bone shard collector, plane, drill, lathe or similar device to form the at least partially decalcified cortical elongate bone shards and/or fluff of the bone particles, wherein the at least partially decalcified cortical elongate bone shards and/or fluff are branched and fragmented, wherein the solid construct is free of bonding material, wherein the bone particles are at least 50% decalcified, wherein drying the mixture of hydrated bone particles comprises freeze-drying, wherein drying the mixture of hydrated bone particles comprises drying by hypothermic dehydration, wherein drying the mixture of hydrated bone particles comprises drying to between 10% and 6% residual moisture by weight, wherein the bone tissue was dehydrated to less than 10% residual moisture by weight, wherein the bone particles further comprise partially and/or wholly decalcified rehydrated bone particles comprising micronized particles processed to form a cellular bone matrix, wherein the bone particles further comprise truncated bone particles having an average particle size greater than 50 microns and an average length dimension less than about 1 mm, wherein the solid construct includes at least 90% by weight of the at least partially decalcified cortical elongate bone shards and/or fluff, and wherein the bone particles were dried under pressure.
The Teachings of the Cited Art
Malinin '641 discloses methods for preparing compressed, dehydrated, decalcified bone, the method comprising compressing the bone while hydrated from a first form to a second form, and drying the bone during compression (see Abstract; see also, ¶[0019]), wherein the bone graft may comprise an allograft for human implantation, the bone comprising strips of whole bone sectioned from a larger whole bone, and may comprise any desired size or shape, e.g., cross section, angles, faces, volume, or combinations of dimensions, such as cubical, cylindrical, geometric, non-geometric, or irregular (see ¶[0020]), wherein compressing the bone includes positioning the bone in a compression device (see ¶[0021]), wherein drying the bone may comprise hypothermally dehydrating the bone (see ¶[0022]), wherein the method comprises harvesting whole bone from a donor, such as a human (see ¶[0023]), wherein the harvested bone sections or strips of may be preserved by dehydration, for subsequent rehydration, such as in a decalcifying solution, or prior to contacting a decalcifying solution (id.), wherein the bone is decalcified by contacting bone particles with a decalcifying solution, such as 1N HCI; citric acid, 5% to 20% w/v; 0.24M disodium or tetrasodium salts of EDTA in a balanced salt solution, saline, or water neutralized to a pH around 6.8 to 7.2 with NaOH, and a mixture of 5M EDTA and 5M citric acid (see ¶[0024]), wherein the bone particles of the dehydrated bone allograft, in the compressed form, are 20% to 80% decalcified, or are 50% to 60% decalcified (see ¶[0025]), wherein the bone grafts comprise an allograft of decalcified cancellous or cortical bone (see ¶[0028]; see also, ¶[0042]), wherein a greater percentage of growth factors has been retained through the decalcification process to thereby stimulate recruitment and differentiation of native/host cells (see ¶[0039]), wherein the bone material is derived from a human, or otherwise is at least partially derived from human origin, prepared under various in situ or ex situ environments, including under artificial, laboratory, or human manipulated conditions (see ¶[0052]), wherein the bone may be prepared by preserving the bone by freeze drying such that the decalcification process may be continued using the freeze-dried bone at a later time (see ¶[0053]), wherein the bone material can be dehydrated by hypothermal dehydration or by chemical dehydration, wherein hypothermal dehydration comprises drying bone tissues in a vacuum at temperatures from 1 to 20° C (see ¶[0054]), wherein ground or bone particulate may be used in addition to whole bone (see ¶[0055]), wherein decalcification may be performed only to render cancellous bone soft and compressible, or to decalcify cortical bone plates, yielding a residual calcium of about 8% of the original level (see ¶[0056]), wherein the extent of decalcification can be controlled by varying the concentration of an acidic decalcifying solution, or by increasing or decreasing the time the bone is exposed to the decalcification solution (see ¶[0057]), wherein extent of decalcification can affect the availability of bone morphogenic proteins to be released from implanted bone material in vivo (see ¶[0058]), wherein decalcification under conditions to minimize BMP loss from the treated bone comprises use of a decalcification solution comprising EDTA and citric acid (see ¶[0063]), wherein, after decalcification, the whole or sectioned bone may be cut into strips to be compressed (see ¶[0066]), and wherein decalcified bone is compressed while in the hydrated state and then dehydrated while in the compression device (see ¶[0067]). The reference does not expressly disclose bone particles dried to between 10% and 6% residual moisture by weight, or preparation of implants comprising micronized particles of bone with sizes greater than 50 mm, and with lengths of from 1- 7 mm, or preparation of compositions comprising constructs with bone shards or fluff at 70% wgt, or more, or at 90% wgt, or more, wherein at least a portion of the elongated particulate bone particles are branched. The teachings of Malinin ‘634 and Malinin (2009) remedy those deficiencies.
Malinin '634 discloses bioactive implants, and methods of making same, and compositions comprising bone microparticles in a solution, wherein the compositions harden upon desiccation into bioactive implants (see Abstract; see also ¶[0034]), wherein the size of the bone microparticles is from about 20 µm to about 800 µm (see ¶[0013]; see also ¶[0041]), wherein the bone microparticles are freeze-dried and processed, which process includes repeated washing in warm saline, or other balanced salt solutions, to remove undesirable constituents, and freeze-drying to a residual moisture of 5 - 6%, or less (see ¶[0154]), wherein the bone microparticles in a disclosed composition can be decalcified, or partially decalcified (see ¶[0191]), wherein the compositions comprise about 10% to about 70% w/v of bone microparticles (see ¶[0193]), wherein the bone microparticles are obtained from an allogeneic source, a syngeneic source, or an autogeneic source, such as a cadaver (see ¶[0194]), wherein the bioactive implants are made by a process comprising the steps of preparing a composition comprising bone microparticles in a solution, wherein the size of the bone microparticles is from about 20 µm to about 800 µm, adding the solution to a mold, and desiccating the composition (see ¶[0249]), wherein the desiccating the occurs in a vacuum (see ¶[0256]), wherein desiccating the composition comprises freeze-drying the composition (see ¶[0257]), wherein the composition is dessicated by hypothermic dehydration (see ¶[0292]), and wherein desiccating the compositions produces hardened bioactive implants having a predetermined size and shape (see ¶[0391]).
Malinin (2009) discloses a comparison of freeze-dried cancellous and cortical particulate bone allograft using a non-human primate model (see Abstract), wherein the size of bone allograft particles is important in promoting bone regeneration, and freeze-dried allogeneic bone preparations induce bone regeneration faster than their frozen counterparts (see p. 420, 2nd col., pt para.), wherein defects 9 to 10 mm in diameter and 15 mm in depth were filled with either cortical or cancellous particulate bone, 90 to 300 µm in size (see p. 421, 2nd para.), wherein bone defects in the femur and the tibia of experimental animals were filled with freeze-dried cortical bone allografts with particle sizes of 1 to 2 mm, 800 to 500 µm, 500 to 300 µm, 300 to 90 µm, 250 to 125 µm, 125 to 106 µm, 106 to 75 µm, and 75 to 25 µm (see p. 422, 1st col.), wherein, while allowing for vascular ingrowth from the periphery of allograft-host interface, and that non-demineralized bone offers a biomechanical and chemical advantages (see p. 422, 3rd col., 5th para.), wherein bone particles in the specified size range of 90 - 300 µm induced osteoclast activity, as well as osteoblast activity, and they were rapidly vascularized and formed new bone (see p. 423, 1st col., 1st para.), and wherein this particle size selection allows not only for the rapid vascularization of grafted site but also for the leaching of bone morphogenetic proteins and other bone growth factors (see p. 423, 1st col., 2nd para.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare bone implant materials comprising compressed, dehydrated, decalcified bone by methods comprising compressing the bone while hydrated from a first form to a second form, and drying the bone during compression, wherein the bone graft comprises an allograft for human implantation, the bone comprising strips of whole bone sectioned from a larger whole bone, and may comprise any desired size or shape, wherein compressing the bone includes positioning the bone in a compression device, wherein drying the bone may comprise hypothermally dehydrating the bone, wherein the method comprises harvesting whole bone from a donor, such as a human, wherein the harvested bone sections or strips of may be preserved by dehydration, for subsequent rehydration, such as in a decalcifying solution, or prior to contacting a decalcifying solution, wherein the bone particles of the dehydrated bone allograft, in the compressed form, are 20% to 80% decalcified, wherein the bone grafts comprise an allograft of decalcified cancellous or cortical bone, wherein the bone material is derived from a human, wherein the bone is preserved by freeze drying, hypothermal dehydration, or chemical dehydration, wherein ground bone or bone particulate is used in addition to whole bone, wherein decalcification is performed to render cancellous bone soft and compressible, or to decalcify cortical bone plates, yielding a residual calcium of about 8% of the original level, wherein, after decalcification, the whole or sectioned bone may be cut into strips to be compressed, and wherein decalcified bone is compressed while in the hydrated state and then dehydrated while in the compression device, as taught by Malinin '641, wherein the compositions comprise bone microparticles in a solution that harden upon desiccation into bioactive implants, wherein the bone microparticles are freeze-dried to a residual moisture of 5 - 6%, or less, wherein the bone microparticles solutions comprise about 10% to about 70% w/v of bone microparticles, wherein the solutions are added to a mold, and desiccated, and wherein desiccating the compositions produces hardened bioactive implants having a predetermined size and shape, as taught by Malinin '634, and wherein the size of bone microparticles is important in promoting bone regeneration, wherein defects 9 to 10 mm in diameter and 15 mm in depth are filled with either cortical or cancellous particulate bone, 90 to 300 µm in size, wherein bone defects in the femur and the tibia of experimental animals were filled with freeze-dried cortical bone allografts with particle sizes of 1 to 2 mm, 800 to 500 µm, 500 to 300 µm, 300 to 90 µm, 250 to 125 µm, 125 to 106 µm, 106 to 75 µm, and 75 to 25 µm, wherein particles in the range of 300 to 90 µm produced rapid healing by direct ossification, while particles below 100 µm had a significantly reduced osteogenic potential, particles in the range of 75 to 25 µm failed to heal the defects altogether, and healing of defects packed with particles larger than 300 µm was slower than with 300 to 90 µm grafts, with the size of the particulate graft is of importance because it allows for compacting of the graft while allowing for vascular ingrowth from the periphery of dehydration, wherein ground bone or bone particulate is used in addition to whole bone, wherein decalcification is performed to render cancellous bone soft and compressible, or to decalcify cortical bone plates, yielding a residual calcium of about 8% of the original level, wherein, after decalcification, the whole or sectioned bone may be cut into strips to be compressed, and wherein decalcified bone is compressed while in the hydrated state and then dehydrated while in the compression device, as taught by Malinin '641, wherein the compositions comprise bone microparticles in a solution that harden upon desiccation into bioactive implants, wherein the bone microparticles are freeze-dried to a residual moisture of 5 - 6%, or less, wherein the bone microparticles solutions comprise about 10% to about 70% w/v of bone microparticles, wherein the solutions are added to a mold, and desiccated, and wherein desiccating the compositions produces hardened bioactive implants having a predetermined size and shape, as taught by Malinin '634, and wherein the size of bone microparticles is important in promoting bone regeneration, wherein defects 9 to 10 mm in diameter and 15 mm in depth are filled with either cortical or cancellous particulate bone, 90 to 300 µm in size, wherein bone defects in the femur and the tibia of experimental animals were filled with freeze-dried cortical bone allografts with particle sizes of 1 to 2 mm, 800 to 500 µm, 500 to 300 µm, 300 to 90 µm, 250 to 125 µm, 125 to 106 µm, 106 to 75 µm, and 75 to 25 µm, wherein particles in the range of 300 to 90 µm produced rapid healing by direct ossification, while particles below 100 µm had a significantly reduced osteogenic potential, particles in the range of 75 to 25 µm failed to heal the defects altogether, and healing of defects packed with particles larger than 300 µm was slower than with 300 to 90 µm grafts, with the size of the particulate graft is of importance because it allows for compacting of the graft while allowing for vascular ingrowth from the periphery of allograft-host interface, wherein bone particles in the specified size range of 90-300 µm induced osteoclast activity, as well as osteoblast activity, and were rapidly vascularized and formed new bone, and wherein this particle size selection allows not only for the rapid vascularization of grafted site but also for the leaching of bone morphogenetic proteins and other bone growth factors, as taught by Malinin (2009). One of ordinary skill in the relevant art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of Malinin (2009) to the effect that particles in the range of 300 to 90 µm produced rapid healing by direct ossification, while particles below 100 µm had a significantly reduced osteogenic potential, particles in the range of 75 to 25 µm failed to heal the defects altogether, and healing of defects packed with particles larger than 300 µm was slower than with 300 to 90 µm grafts (see p. 422, 2nd col., 1st para.).
With respect to the limitation recited in claims 1 and 19 directed to the solid constructs prepared by the method of the invention including at least 70% wgt, or at least 90% wgt bone microparticles, the Examiner first notes that Malinin '634 discloses the preparation of bone implants by adding a solution containing bone microparticles to a mold and dessicating the contents of the mold to form a solid, implantable construct. The concentration of bone particles in the solution is 70% w/v. It is the Examiner's position that dessication (removal of fluid solvent) would result in even higher relative contents of the bone particles in the resulting implants such that, after dessication to residual moisture contents well below 10% which would yield relative bone particle contents in excess of 90% wgt that read on the limitation recited in claim 19.
With respect to the limitations recited in claims 1 and 18 directed to the dimensions of the bone particles in the bone graft compositions of the invention, the Examiner notes that the references do not expressly teach specific quantitative dimensions for the bone particles used in the disclosed bone grafts. However, it is the Examiner's position that the cited art teaches a range of loadings of bone particles that significantly overlaps with the claimed ranges and, as such, would render the claimed invention obvious. See MPEP § 2144.05. "In the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)."
Further with respect to the limitation recited in claim 18, which limitation is directed to the dimensions of "truncated" bone particles, it is the Examiner's position that such limitations are merely directed to a mixture of bone particles comprising particles of different sizes, and that such mixtures of bone particle sizes are encompassed by the reference's disclosures as cited immediately above.
With respect to the limitation recited in claim 19 directed to bone shards or fluff being "branched, fragmented, or both," the Examiner notes that the reference does not use such descriptors in connection with the harvested bone particles However, neither the claims nor Applicant's specification provide a precise definition of the terms used. In the absence of any specific meaning intended by Applicant, it is the Examiner's position that one of ordinary skill in the relevant art would interpret the meaning of the term consistent with its ordinary meaning to include pieces or, in the case of bone material, shards, of bone fragments, which particles, as disclosed by the reference, may be in any shape, particularly those that have been reduced in size. In light of this interpretation, the bone particles disclosed in the cited references would meet this definition and read on the claim limitations in question, rendering them obvious.
With respect to claim 11, which claim recites a limitation directed to the solid construct of the invention being "free of bonding materials," the Examiner notes that the cited references do not expressly address such compositional characteristic of the disclosed compositions. However, in looking more closely to the disclosure of Malinin '641, the reference is replete with teachings directed to what the compositions comprise (see, for example, ¶[0028], [0034], [0039], [0043]), yet none of these teachings disclose the use of a component that is characterized as "a bonding material," nor do they disclose specific components that Applicant's specification, at ¶[0065], list as exemplary bonding materials, such as "glycerol, collagen, fibrin, hydroxyapatite, calcium sulfate, polyether ketone (PEEK), and osteocell cellular bone material." In the absence of any disclosure directed to what could be construed as "bonding materials," either generically, or in terms of specific components, it is the Examiner's position that the limitation is necessarily met by the cited reference.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1- 3, 5, 6, 11 - 14, and 17 - 20 would have been obvious within the meaning of 35 USC
§ 103.
Claims 4 and 7 are rejected pursuant to 35 U.S.C. § 103, as being obvious over Malinin '641, in view of Malinin '634, and Malinin (2009), as applied in the above rejection of claims 1 - 3, 5, 6, 11 - 14, and 17 - 20, and further in view of Favinger, J., et al., RadioGraphics 35(3): 780 - 792 (2015) ("Favinger (2015)").
The Invention As Claimed
The invention with respect to claim 1 is described above. In addition, Applicant claims a method of making a bone graft composition comprising a mixture of bone particles, wherein the bone tissue was harvested postmortem or from surgically removed bone specimens, and wherein human postmortem bone was excised aseptically without muscle tendon or fasciaI attachments.
The Teachings of the Cited Art
The disclosures of Malinin '641, Malinin '634, and Malinin (2009) are relied upon as set forth in the above rejection of claims 1 - 3, 5, 6, 11 - 14, and 17 - 20. The references do not disclose use of bone tissue harvested aseptically postmortem without muscle tendon or fascial attachments. The teachings of Favinger (2015) remedy that deficiency.
Favinger (2015) discloses the use of allografts obtained from cadaveric donors to prepare implants for transplantation into living patients (see Abstract), wherein the use of allografts in patients with large-volume bone loss often preserves limb function, obviating amputation (see p. 781, 1st col., 1st para.), wherein osteochondral allografts consist of cadaveric bone, cartilage, and soft tissues that can be transplanted into living patients (see p. 781, 1st col., 2nd para.), wherein allografts are provided by cadaveric donors and procured within 24 hours of donor death (see p. 781, 1st col., 4th para.), and wherein allograft tissues are ideally transplanted within 21 days of procurement, and are cleaned extensively and can either be frozen or kept fresh at 4°C until they are needed, with fresh allografts providing the advantage that chondrocytes remain viable, which has been shown to improve graft survivorship (see p. 781, 2nd col., 1st para.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare bone implant materials comprising compressed, dehydrated, decalcified bone by a method comprising compressing the bone while hydrated from a first form to a second form, the bone being dried during compression, wherein the bone graft comprises an allograft for human implantation, according to the teachings of Malinin '641, Malini '634, and Malinin (2009), wherein the allograft bone is derived from a human cadaveric donor, as taught by Favinger (2015). One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in doing so, by the express teachings of Favinger (2015) to the effect that use of allograft bone from cadaveric donors allows for the repair of bone voids of greater volume than would be possible with autologous donor bone.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined
by claims 4 and 7 would have been obvious within the meaning of 35 USC§ 103.
Claim 8 - 10 are rejected pursuant to 35 U.S.C. § 103, as being obvious over Malinin '641, in view of Malinin '634, and Malinin (2009), as applied in the above rejection of claims 1- 3, 5, 6, 11 - 14, and 17 - 20, and further in view of Achour, A., et al., Materials 12: 3695 (9 November 2019) ("Achour (2019)").
The Invention As Claimed
The invention with respect to claim 1 is described above. In addition, Applicant claims a method of preparing a bone graft composition comprising a mixture of bone particles, wherein the bone particles are dried in the constraining device, wherein dehydrated cortical bone tissue is cut with a bone shard collector, plane, drill, lathe or similar device to form at least partially decalcified cortical elongate bone shards and/or fluff from the bone particles, and wherein the at least partially decalcified cortical elongate bone shards and/or fluff are branched and fragmented.
The Teachings of the Cited Art
The teachings of Malinin '641, Malinin '634, and Malinin (2009) are relied upon as set forth in the above rejection of claims 1 - 3, 5, 6, 11 - 14, and 17 - 20. The references do not expressly disclose a method of making a bone graft composition bone particles wherein the particles are dried in the a constraining device, wherein dehydrated cortical bone tissue is cut with a bone shard collector, plane, drill, lathe or similar device to form at least partially decalcified cortical elongate bone shards and/or fluff from the bone particles, and wherein the at least partially decalcified cortical elongate bone shards and/or fluff are branched and fragmented. The teachings of Achour (2109) remedy those deficiencies.
Achour (2019) discloses that bone drill chips that are collected during implant site preparation can be reused as autologous bone-grafting material for alveolar ridge augmentation (see Abstract), wherein a relatively simple method to obtain autologous particulate bone-grafting material is the removal from the retromolar region or the chin region by using bone scrapers or raspatories (see p. 2, 2nd para.), wherein it is possible to collect bone chips produced during implant site drilling, and to reuse them as bone-grafting material (see p. 2, 3rd para.), wherein these bone chips consist of a mixture of cancellous bone chips, and cortical bone particles with high mechanical stability, recognizing that it is important not to disrupt or irreversibly damage these cells, as well as to preserve their vitality, and thus their regenerative potential, because this has a significant influence on the success of bone augmentation (see p. 2, 4th para.), wherein the factors that have an influence on surrounding bone during the preparation of the implant site and, in consequence, on the subsequent osseointegration of the implant, also affect the extracted bone chips given that the multifactorial process of energy input during machining of bones, for example by drilling, is very complex, and not directly assessable by a clinician, wherein, for a given instrument geometry, the input of mechanical energy into the bone tissue depends on the rotational speed and feed rate, and it is converted into cutting energy and frictional heat during drilling (see p. 2, 5th para.), wherein not only the drilling speed, but also other process parameters, affect the heat generation and mechanical stress, such as drilling feed rate, applied axial load, drilling depth, use of graduated versus one-step drilling, intermittent versus continuous drilling, as well as the properties of the drill itself, are likely to also have an impact in terms of temperature and mechanical load, such as drill bit geometry (shape, diameter, point angle), sharpness, drill material, and wearing, with the drill geometry influencing particle size and the shape of the bone chips (see p. 2, last para - p. 3, 1st para.), wherein the sizes of the bone chips produced by the different drills varied widely, with particles ranging in size from micrometers to millimeters in each sample (see p. 13, last para.; see also Figure 8), and wherein the mixture of large and small bone particles combines the respective advantages of the different particle sizes, where the osteoconductivity of the small particles combines with the osteogenicity and mechanical stability of the large particles (see p. 16, last para.).
Claims 15 and 16 are rejected pursuant to 35 U.S.C. § 103, as being obvious over Malinin '641, in view of Malinin '634 and Malinin (2009), as applied to claims 1- 3, 5, 6, 11-14, and 17 - 20, above, and further in view of US 10,821,004 to Schallenberger, M., et al., claiming priority to
30 June 2015 ("Schallenberger '004").
The Invention As Claimed
The invention with respect to claim 1 has been described above. In addition, Applicant claims a method of making a bone graft composition comprising a mixture of bone particles, wherein drying a mixture of hydrated bone particles comprises drying to between 10% and 6%
residual moisture by weight, or to less than 10% residual moisture by weight.
The Teachings of the Cited Art
The disclosures of Malinin '641, Malinin '634, and Malinin (2009) are relied upon as set forth in the above rejection of claims 1 - 3, 5, 6, 11- 14, 17, 18, and 20. The references do not disclose use of bone tissue that is dried to a residual moisture level of from 2 - 10% wgt, or less than 10% residual moisture by weight, using freeze-drying, hypothermic dehydration, without freezing, or chemical dehydration prior to or after being one or more of partially or wholly decalcified, rehydrated, cut, and/or particulated. The teachings of Schallenberger '004 remedy those deficiencies.
Schallenberger '004 discloses bone-based implants for bone fusion and bone regeneration where the implant is maintained in the desired compressed state upon implantation (see Col. 1, I. 66 - Col. 2, I. 2), wherein the bone materials in the implants can be exposed to drying or lyophilization conditions, and shaped and sized to specific dimensions to enhance entanglement and subsequent final product self-adhesion, flexibility, and compressibility (see Col. 2, II. 23 - 27), wherein the residual moisture content of the product can be less than about 6% wgt (see Col. 2, II. 29- 31), wherein, following compression, the rehydrated product can return to its original shape of the product before dehydration (see Col. 2, II. 34- 36), wherein the bone materials can be cortical bone, cancellous bone, or combinations thereof, and the bone can be fully demineralized, partially demineralized, mineralized, or any combinations thereof, such that, when dehydrated, the bone-based implants can rehydrate in at least one aqueous liquid, such as water, saline, buffer, balanced salt solution, blood, bone marrow aspirate, plasma, or combinations thereof (see Col. 2, II. 38 - SO), wherein bone-based implant materials are prepared by a process that includes cutting bone into bone fibers, then entangling the bone fibers in an aqueous solution to produce entangled fibers, which fibers are then are placed in a mold and dried (see Col. 2, II. 64 - 67), wherein drying can include blowing gas through the containing device and removable components and/or subjecting the apparatus to reduced pressure, heating, lyophilization (under reduced pressure), or a combination of heating and vacuum, wherein the gas used can include nitrogen, helium, argon, and combinations thereof, the drying being performed under reduced pressure between about 1 Torr and about 740 Torr, and can include air flow (see Col. 5, II. 28- 30), and wherein the process can include inserting the product into a void in a dehydrated state, after which the product is rehydrated, or the product can be rehydrated, compressed, and then inserted into a void in a hydrated state (see Col. 6, II. 47 - 51).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare bone implant materials comprising compressed, dehydrated, decalcified bone by a method comprising compressing the bone while hydrated from a first form to a second form, the bone being dried during compression, wherein the bone graft comprises an allograft for human implantation, according to the teachings of Malinin '641, wherein the bone particles are dehydrated to a residual moisture content of 10% weight, or less, as taught by Schallenberger '004. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of the reference as to the shaping and insertion of implants comprising the bone material upon dehydration and rehydration to product a final implant device. In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 15 and 16 would have been obvious within the meaning of 35 USC § 103.
Obviousness-Type Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 - 20 are rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1- 7, 11, and 12 of commonly assigned U.S. Patent No. 9,610,143 ("the '143 patent"), in view of Malinin '641, Malinin '634, Malinin (2009), Achour (2019), and Schallenberger '004. The instant claims have been described supra. Although the claims at issue are not identical, they are not patentably distinct from each other. The identified claims of the '143 patent are directed to a method of making and using a bone graft composition comprising decalcifying whole bone by contacting the bone with a decalcifying solution, wherein the bone comprises whole trabecular bone; applying force to compress the decalcified whole bone from a first form to a second form, the second form having a conical shape and compressed relative to the first form, wherein the bone is hydrated when compressed; drying the decalcified and compressed whole bone while maintaining compression, wherein, when dried, the bone substantially retains the second form, and wherein drying comprises hypothermically dehydrating the bone using hypothermic dehydration; and inserting the decalcified, compressed and dried whole bone at a post extraction tooth socket, wherein the decalcified bone in the first form defines empty trabecular spaces that are reduced or obliterated when the decalcified bone is compressed to the second form, and wherein, when rehydrated following insertion at the post extraction tooth socket, the decalcified bone decompresses to obliterate space between the decalcified bone and the tooth socket and the empty trabecular spaces allow vascular ingrowth and reossification, wherein the decalcified, compressed and dried bone comprises an allograft configured for human implantation, wherein the decalcified bone is 20% to 80% decalcified, or 50% to 60% decalcified, and wherein the method further comprises sectioning fresh or dehydrated bone prior to decalcifying the bone. The enumerated claims of the '143 patent do not disclose bone microparticles used in the preparation of bone grafts wherein the microparticles are dried to between 10% and 6% residual moisture by weight, or preparation of implants comprising micronized particles of bone with sizes greater than 50 mm, and with lengths of from 1 - 7 mm, or preparation of compositions comprising constructs with bone shards or fluff at 70% wgt, or more, or at 90% wgt, or more, or bone tissue that was harvested postmortem, or from surgically removed bone specimens, wherein human postmortem bone was excised aseptically without muscle tendon or fasciaI attachments, or dehydrated cortical bone tissue that is cut with a bone shard collector, plane, drill, lathe or similar device. These deficiencies are remedied by the teachings of Malinin '634, Malinin (2009), Achour (2019), and Schellenberger '004, as disclosed above.
The claims of the instant application are obvious variants over claims 1, 3, 5, 6, 11, and 13 of commonly assigned U.S. Patent No. 9,610,143 because it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to modify the method of claims 1 - 7, 11, and 12 of the '143 patent according to the teachings of the cited references as applied in the above obviousness rejections, as motivated as described above.
Therefore, claims 1 - 20 are directed to an invention not patentably distinct from claims 1 - 7, 11, and 12 of commonly assigned U.S. Patent No. 9,610,143, as set forth above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned '070 patent, discussed above, would be prior art to the noted claims pursuant to 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date pursuant to 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue, the Applicant or patent owner can provide a statement pursuant to 35 U.S.C. § 102(b)(2)(C) and 37 CFR § 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the Applicants or the patent owner can provide a statement pursuant to 35 U.S.C. § 102(c) and 37 CFR § 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date pursuant to 35 U.S.C. § 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, Applicants may act to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David J Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619